Effect of Predictive Model on Double-Balloon Enteroscopy

Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial

The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.

Study Overview

• Status: Recruiting
• Conditions: Double-balloon Enteroscopy
• Intervention / Treatment: Other: Predictive model

Detailed Description

Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation.

Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.

• Study Type: Interventional
• Enrollment (Estimated): 338
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuli Zuo; Phone Number: 86-0531-82165292; Email: xiulizuo@sdu.edu.cn

Study Locations

• China
  • Shandong
    • Dezhou, Shandong, China
      • Recruiting
      • Dezhou People's Hospital
    • Qingdao, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University (Qingdao)
    • Yantai, Shandong, China
      • Recruiting
      • Yantai Affiliated Hospital of Binzhou Medical University
    • Zaozhuang, Shandong, China
      • Recruiting
      • Zaozhuang Municipal Hospital
  • Shangdong
    • Jinan, Shangdong, China
      • Recruiting
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
2. CT scan of the abdomen was performed within two weeks before enteroscopy

Exclusion Criteria:

1. cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
2. poor quality of bowel preparation
3. high risk esophageal varices
4. the insertion route is not oral or anal because of changes in anatomical structure
5. unsuitable for general anesthesia
6. pregnant women
7. unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Predictive model group; Endoscopists will obtain the predictive model intervention.	Other: Predictive model; Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
No Intervention: Control group; Endoscopists will not obtain the predictive model intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total enteroscopy rate	Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Positive findings included vascular malformation, ulcer, polyp, diverticulum and others.	8 months
Procedural time	The total time of antegrade and retrograde insertions	8 months
Adverse events	Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.	8 months

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Dezhou People's Hospital; Qilu Hospital of Shandong University (Qingdao); Zaozhuang Municipal Hospital; Yantai Affiliated Hospital of Binzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Estimated): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Artificial Intelligence; Algorithms; Mathematical Concepts; Prediction Methods, Machine; Predictive Learning Models
• Other Study ID Numbers: QLCR20250630

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No